Finding the Care Path of Least Resistance: Weighing the Risks and Rewards of Standardizing Care

Friday, April 1, 2016

Greater exploration of the “hows,” the “whys,” and the heterogeneity of hematologic conditions in recent years has led to greater variety of treatments available to patients with blood disorders. These advances in care, though, have come at a time when many health-care organizations are trying to navigate how to provide standardized, value-based care for patients. Clinical care paths, sometimes going hand-in-hand with alternative payment models, have emerged as one approach to ensure care for hematologic malignancies is effective – from the standpoint of both patient outcomes and cost.

“A care path is an evidence-based (ideally) or expert opinion–based guideline on how care should be delivered,” David L. Longworth, MD, chief medical officer at Lahey Health Community Practices in Burlington, Massachusetts, and professor of medicine at Tufts University School of Medicine, explained to ASH Clinical News. “It can be a very focused guideline around a specific procedure, or it can be more ‘fully baked,’ meaning it covers a clinical problem across the entire care continuum.”

“The idea behind using care paths is to standardize, to as great of an extent as possible, the way we deliver care,” Dr. Longworth said. “With standardization, the goal is to achieve outstanding quality at an affordable price and eliminate unnecessary variation in treatment.”

Until recently, Dr. Longworth headed Cleveland Clinic’s Value-Based Care Steering Committee and was involved in the development of evidence-based care paths across a variety of disease types there.

When the Cleveland Clinic began to look into developing clinical care paths, it reached out to Intermountain Healthcare, a health-care organization in Salt Lake City, Utah, which Dr. Longworth said was an early leader in developing what it called “care process models” about 15 years ago.

“They identified chronic diseases or procedures and began to deploy multidisciplinary teams of content experts in the delivery of care to create systems for managing diabetes, hypertension, joint replacement surgery, and other areas,” Dr. Longworth said. “In recent years, as value-based care and hospital-based purchasing have gained prominence, more and more health systems have recognized that standardization leads to better quality care at a lower cost.”

Although originally applied to hospital readmissions or post-operative wound infections, the use of these care paths has expanded more recently into specialty areas including hematology and oncology. ASH Clinical News spoke with several physicians about the effects of care paths on patient care, and the alternative payment models with which they can sometimes go hand-in-hand.

Standardization of Care, Reduced Variability

How is a typical care path in the area of hematology developed? Brian J. Bolwell, MD, chairman of the Taussig Cancer Institute and professor of medicine at Cleveland Clinic, offered the following example for a care path that defines the treatment plan for patients with newly diagnosed stage 3 or 4 B-cell non-Hodgkin lymphoma: Experts at the institution get together to discuss what should be the standard work-up of these patients, including what images should be obtained and when, what laboratory values are needed, the preferred initial treatment plan, which drug regimen to use and how often, and what surveillance strategy should be used. Critical to this process is identifying the evidence that supports these decisions. Care paths can be developed at an institutional level, or by a committee of experts at a medical society or national level, ideally using standardized methodology in identifying preferred treatment strategies in the absence of any conflict of interest.

“There are many ways to treat cancers – more than ever – and by coming up with a common approach, there is a simple reduction in variability that reduces people ordering whatever they want, whenever they want, without the data to back up those decisions,” Dr. Bolwell said. “Things get standardized and fewer resources are consumed.”

At Cleveland Clinic, Dr. Bolwell said that multidisciplinary teams meet several times a year to keep these care paths current, incorporating the newest technology or drugs. They also embed quality metrics into the paths to track their use and efficacy.

“For example, for some cancers treated by surgery, the number of lymph nodes sampled is a quality metric,” he explained. “Or for B-cell lymphoma, a quality metric might measure whether or not the patient got a pretreatment PET scan.” By tracking these metrics, the institution can track adherence to a pathway and identify areas for improvement.

Increased Value

According to Dr. Longworth, data that back up the idea that clinical care paths provide value and save resources are only beginning to emerge. Most of the evidence at this point is anecdotal.

At the 2014 ASH Annual Meeting, Dr. Bolwell and colleagues presented early data from a study conducted at Cleveland Clinic about the care path for upfront treatment of patients with myeloma, finding that most patients achieved uniform disease control using fewer drugs than the standard approach.1

In the pathway, patients with multiple myeloma were started on a two-drug regimen (lenalidomide and dexamethasone) as opposed to a three-drug regimen (bortezomib, lenalidomide, and dexamethasone), both of which may be considered standards of care. Care-path developers selected the two-drug regimen to avoid the higher risk for side effects (including peripheral neuropathy), and higher costs associated with the three-drug regimen, without a clear-cut improvement in overall survival. If patients did not have at least a minimal response (<50% decrease in M protein) after the first treatment cycle, or at least partial response (>50% decrease in M protein) after the second cycle, treatment could be adapted with sequential addition of agents.

After 15 months of implementation, the 24 patients who were treated following the care path achieved minimal response or better, with 60 percent of patients requiring treatment with only two drugs. “Overall survival will be the ultimate assessment of the utility of this approach, but response assessments to date support ongoing utilization of the care path,” the authors wrote. In addition, compared with standard use of the three-drug regimen, an adapted approach reduced the risk of peripheral neuropathy and lowered costs, with a savings in drug costs alone of more than $4,000 per treatment cycle.

More recently, at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting, Cleveland Clinic researchers presented data from an evaluation of a clinical care path’s effect on treatment decisions and health-care costs for non-small cell lung cancer.2 In just its first year of use, use of the care path led to 93 percent of patients receiving the recommended front-line treatment (vs. 71% in the comparison group) and significantly lowered the number of patients who received a non-recommended drug (9% vs. 39% in the comparison group). The researchers calculated that, overall, charges for chemotherapy decreased by nearly half.2 “Multiple, different standards of care exist for non-small cell lung cancer, and no one standard of care has proven to be better for survival,” the authors wrote, however, the regimen selected for this study was shown to demonstrate the “best value for care, meaning lower costs and lower rates of adverse effects, while achieving the same survival rates and comparable quality of life.”

Shoving Into a One-Size-Fits-All Model?

“Our use of care paths is couched in certain factors,” Dr. Bolwell noted. “Number one: Any time a patient is eligible for a clinical research trial, that is the preferred approach. Number two: There are defined ways to incorporate new drugs, if a new drug has been shown to be better than the standard of care.”

While Dr. Bolwell believes that care paths have played a big part in Cleveland Clinic’s strategy, he also acknowledged that their use can be too rigid – a potential drawback that critics of care paths have been quick to point out.

“It is important to remember that not every patient will fit into a care path. Clinical judgment still trumps the use of a care path,” Dr. Longworth said. “This is especially true in malignancies, where we have seen a burgeoning number of incredibly expensive cancer treatments and the evolution of personalized medicine, which enable us to test tumors for their receptiveness or refractoriness to highly expensive biologics.”

In January, ASCO released a statement calling for improvements to clinical pathway programs for patients with cancer and hematologic malignancies.3 The statement, prepared by a task force of physicians, raised concerns about whether or not the growing proliferation of clinical care paths has affected access to quality care for patients.

In its statement, the task force said that care paths need to be expanded to address the full spectrum of cancer, including services such as palliative care, and be updated regularly to reflect the most up-to-date, evidence-based care. It also called for increased transparency in how care paths are developed and for systems to ensure that pathways are implemented in a manner that supports high-quality patient care. Finally, the task force emphasized the need to recognize patient variability and physician autonomy; when evidence dictates it, physicians should be allowed to diverge from pathways.

Dr. Bolwell said that he believes there is a large appetite for care paths, especially among smaller organizations that may not have the resources to develop standardization on their own.

“A lot of organizations have reached out to us to affiliate with us and have access to our care paths because they simply do not know how to manage the complexity of, for example, genomics in the diagnosis of cancers or when it is appropriate to ask for expanded sequencing of a tumor specimen,” Dr. Bolwell said.

However, as discussed in the ASCO task force’s statement, this also raises concerns about how, and by whom, care paths are being developed.

“At Cleveland Clinic, we did see payers getting involved in the development of hematologic malignancy care paths and suggesting which treatment might be best and what services they would reimburse. We jumped in because we wanted to be driving that discussion,” Dr. Longworth said. “I do worry about the commercialization of care paths. It will not be enough to simply publish these paths; organizations have to build or adopt them and then take ownership of the pathways in their own systems – not simply use care paths as a ‘plug-and-play’ system.”

Bundling Up

The effort to standardize care and provide more value has also led to the introduction of alternate payment models, including the bundled payment.

Traditionally, payment models in health care have employed a fee-for-service model, in which a clinician bills and is reimbursed for a single diagnosis made in a patient, visit, or treatment. Critics of this model have suggested that it rewards the quantity of services provided over the quality of service provided.

In contrast, bundled payments are a negotiated, single payment made to providers for bundles of services related to a condition. Although bundled payments were initially used in the primary-care setting, payers are exploring expanding their use into specialty areas including hematology and oncology.

In a bundled payment model, the provider receives a flat fee for the diagnosis of a certain type of cancer. “The care path can help to determine the economics of that,” Dr. Bolwell explained.

“The concept behind bundled payments is that a large amount of risk management for treating a patient is transferred to the organization and the physician who are looking after the patients,” said Michael Lill, MD, director of the Stem Cell and Bone Marrow Transplant Program at Cedars-Sinai Medical Center.

In 2009, UnitedHealthcare launched a pilot program testing bundled payments in five medical oncology groups. Under the program, the clinicians were paid upfront based on an expected cost of the standard of care for the patient’s condition. For chemotherapy administration, for instance, in typical payment models, physicians are reimbursed the amount they paid for the drug plus a percentage of the average sales cost to cover office costs – equating to higher reimbursements for more expensive drugs. Under the pilot program, however, the reimbursements did not vary according to the drugs administered. Instead, chemotherapy was reimbursed at the average sales price.

After three years, 810 patients with breast, colon, or lung cancer were treated under this program. An evaluation of improvements in quality and cost reductions demonstrated that the costs of treatment were significantly lower under this model than the predicted costs under a fee-for-service model: $98,121,388 versus $64,760,116 – a 34 percent reduction.4 However, the study did not explore exactly how these cost savings came about.

In the hematology world, the oldest example of bundled payments is in the bone marrow transplant arena, where they have been in use to varying degrees since the 1990s, according to Dr. Lill.

“The bundled payment model for bone marrow transplantation is fairly straightforward because it is a fairly discrete episode of care,” Dr. Lill told ASH Clinical News. “We get paid a certain amount of money to look after a patient from the day we start the process of transplant until about 10 days, or whatever set period, after the transplant is complete.”

According to Dr. Lill, this bundled payment method provides physicians a degree of freedom in clinical decision-making by eliminating the need to ask insurance payers for permission to do things, but also requires physicians to view treatment decisions from a financial perspective and remain cognizant of costs. In addition, bundled payments can prompt organizations to continually re-evaluate institutional processes and standards of care, in an effort to improve the quality of patient outcomes without raising costs, or maintain quality while decreasing costs.

More Standards, More Problems?

“One potential problem with bundled payments is that people can get tempted to cut corners to save money without doing anything to improve outcomes, or perhaps by making outcomes worse,” Dr. Lill said. “There has to be a mechanism in place to make sure that the quality of outcomes is maintained.”

Bone marrow transplantation, for one, is an area in which standards of care are fairly homogenous and well-defined. Most transplant programs are housed within large medical institutions, making the application of bundled payments a bit simpler. However, application of bundled payments is not without risk, according to James L. Gajewski, MD, professor and hematologist at Oregon Health & Science University.

“We have to have outlier clauses [with bundled payments], because our worst patients can use 10 to 100 times as many resources as the average patient,” Dr. Gajewski explained. “I may have a bone marrow transplant patient with congestive heart failure, liver dysfunction, or chronic obstructive pulmonary disease. Caring for these comorbidities alone can cause as much resource use as the pathway for the transplant.”

Because of these unknowns, institutions using bundled payments often have to negotiate the existence of outlier or stop-loss clauses in order to minimize risk.

Even for patients without higher comorbidity burdens, Dr. Gajewski said that stem cell and bone marrow transplants are becoming much more complex.

“The Centers for Medicare & Medicaid Services (CMS) would love to treat all hematologic malignancies the same and establish one fixed rate for transplant, but that’s simply not possible,” Dr. Gajewski said. “If a patient is undergoing an autologous transplant, immunosuppression is not required and there is less risk for infection. Resource use in this setting, then, is different than for matched sibling allogeneic transplant, which is different from resource use for a patient undergoing an unrelated donor transplant. The list goes on.”

Dr. Gajewski gained experience with bundled payments at the University of Texas MD Anderson Cancer Center, where he was involved in writing contracts for bundled payments with a now-defunct payer. At the time, they established that management of any comorbidities a patient presented to transplant with would be excluded from the bundled payment.

“We thought this was a great idea, but the practical application was much different,” he said. “For example, some of the drugs used in transplant patients can cause hypertension, like cyclosporine. Well, if the patient already had hypertension, was it made worse because of cyclosporine or should it be considered a primary disease? If the patient’s serum creatinine goes up because I am giving cyclosporine, but the patient also already had hypertension, how do we bill that? How do we pull out individual labs to identify as not being part of the bundled payment when there have been 20 to 30 labs performed each day for four straight days?”

Widespread use of these bundled payment models could also create access issues for patients who are sicker or less compliant with preventive health care, or the “tail end” of the bell curve, Dr. Gajewski noted. Not every provider takes care of patients representing the full bell-shaped curve, he added. “For example, patients with acute leukemia may be treated in the community, but people with leukemia and heart problems will be sent to an academic center for treatment.”

Despite these questions and concerns, testing of bundled payment models is moving forward. CMS launched its Oncology Care Model that incorporates a two-part payment system for participating practices.5 Participants receive a monthly per-beneficiary, per-month payment, with the potential for a performance-based payment for episodes of chemotherapy care. The model was open to applicants in 2015 and will notify selected participants in spring 2016.

One of the main targets of the program is chemotherapy treatment; the proposal for bundled payment would start on the first day of chemotherapy initiation.

“When this model was introduced, we brought up the issue of patients who might require adjuvant chemotherapy,” Dr. Gajewski said. “If we are responsible for all care starting at chemotherapy initiation and for six months after, that would put the oncologist at risk for the surgery. We are not taking that risk.”

Wave of the Future

There is a definite tension within the health-care community surrounding the use of care paths and bundled payments, according to Dr. Longworth.

“Until very recently, providers have really valued their autonomy and ability to do things their way,” Dr. Longworth said. “As reimbursement gets more challenging and quality metrics get harder to reach, that will provide a growing impetus for the use of care paths.”

Dr. Bolwell agreed. “Academic cancer centers cannot be blind to the realities of the escalating cost of health care,” he said. “Value-based health care is something that is going to happen across the United States.”

As these programs become more widespread, Dr. Longworth emphasized that institutions, payers, and physicians should remember that these care paths and bundled payments will not apply to every patient’s situation. “Clinical judgment is still incredibly important as physicians look at their patients one by one.”—By Leah Lawrence